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Dissolution method development and validation of brexpiprazole

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Original Article

Author Details : Mansi Patole*, Atul Bendale, Vasim Pathan, Sushil Narkhede, Namrata Revar, Anil G Jadhav

Volume : 11, Issue : 3, Year : 2024

Article Page : 245-252

https://doi.org/10.18231/j.ijpca.2024.035

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Abstract

Background: A stability-indicating RP-HPLC method was established and validated for the determination of Brexpiprazole in bulk drug-using 1260 Infinity HPLC having column Hemochrom C-8, 25 cm X 4.6 mm x 5 µ, USP Apparatus Type II (Paddle), and sonicator. The prepared mobile phase was filtered as per the standard procedure. Analysis was carried out at wavelength 227 nm, flow rate 1ml per minute, 18-22 °C temperature, with an injection volume of 50 µl with time 21 minutes.
Results:  It was found that interference of diluent and placebo is not more than 0.5% of Brexpiprazole. The individual % recovery was found to be between 97.0% to 100.0%, the linearity was within the range of 10- 60 µg mL with a Correlation Coefficient of 0.999, Slope of the regression line was found to be 1299178.9578 which means all parameters were found to be within range. In precision % RSD for % released dissolution values were found to be 99.16, in robustness, all the parameters like change in the flow rate, wavelength, and in RPM shows that the developed method was robust.
Conclusion: The proposed approach performed well in terms of sensitivity, precision, accuracy, linearity and range, robustness. The well-known RP-HPLC method for the study of Brexpiprazole was shown to be trustworthy, as well as easy, consistent, cost-effective, and exact. For quality control or routine quantification, this method is applicable to determine Brexpiprazole in a bulk and pharmaceutical dosage form. This developed method required less time.

Keywords: RP-HPLC, dissolution, Brexpiprazole, Development, Validation

How to cite : Patole M, Bendale A, Pathan V, Narkhede S, Revar N, Jadhav A G, Dissolution method development and validation of brexpiprazole. Int J Pharm Chem Anal 2024;11(3):245-252

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